Modulation of Vascular Calcification in Chronic Dialysis Patients
NCT ID: NCT03104166
Last Updated: 2020-01-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
50 participants
INTERVENTIONAL
2018-01-22
2019-08-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Serum samples will be drawn at baseline, after 4, 8 and 24 weeks.
Later, calcifiying vascular smooth muscle cells will be incubated with these serum samples and calcification will be assessed with Alkaline phosphatase and Alizarin staining.
Primary endpoint:
In vitro Calcification of coronary vascular smooth muscle cells (Alkaline Phosphatase/ WST8) after six months
Calcifiying vascular smooth muscle cells will be incubated with serum samples obtained after six months of MCO/HF dialysis and calcification will be assessed with Alkaline phosphatase and WST8.
Secondary Endpoints:
Aortic Pulse wave velocity after 6 months Calcification propensity after 6 months Physical activity level after 6 months
Cell culture: Incubation of VSMC with serum samples obtained after 6 months
* Alizarin staining/WST-8
* Measurement of calcification inhibitors Osteopontin and Matrix Gla Protein in Supernatants
* Apoptosis
The treatment regimen of the patients will not be altered, hence blood flow, dialysate flow as well as dialysis time will remain constant.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Analysis of the Influence of Dialysis Fluid Composition on Vascular Calcification in Patients With Chronic Kidney Disease Undergoing Hemodialysis
NCT07163936
Modulation of Inflammation by Medium Cut Off Membranes
NCT03270371
The Effect of High-flux Hemodialysis and On-line Hemodiafiltration on Endothelial Function.
NCT03942744
Theranova Dialyzer and Chronic Kidney Disease - Mineral Bone Disorder (CKD-MBD)
NCT03169400
Solute Removal With High Volume Hemodiafiltration Versus Long High Flux Hemodialysis
NCT01445366
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
MCO
Patients will be treated thrice weekly with Medium Cut-Off Dialysis membranes.
Medium Cut-Off (MCO) dialysis membrane
Patients will be treated with a CE-certified dialysis membrane that provide enhanced clearance for middle-sized molecules, call Medium Cut-Off membrane.
High-Flux
Patients will be treated thrice weekly with High-Flux Dialysis membranes.
High-Flux dialysis membrane
Control: Patients will be treated with a CE-certified High-Flux dialysis membrane.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Medium Cut-Off (MCO) dialysis membrane
Patients will be treated with a CE-certified dialysis membrane that provide enhanced clearance for middle-sized molecules, call Medium Cut-Off membrane.
High-Flux dialysis membrane
Control: Patients will be treated with a CE-certified High-Flux dialysis membrane.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Chronic dialysis patients for at least 3 months
Exclusion Criteria
* Pregnancy
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Charite University, Berlin, Germany
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Daniel Zickler
MD
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Charité Virchow
Berlin, , Germany
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
ModuVas
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.